Protocol summary
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Study aim
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The efficacy of Cassia Fistula syrup on constipation in pregnant women
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Design
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This study has a control group with parallel design. Sample size, for the error typeI, 5% and power of 80%, in each group was calculated as 22. Considering 20% dropout rate, the final sample size was calculated 35 in each group. Samples were randomly divided into intervention and control groups. permuted block Randomization will be used with block of 4.
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Settings and conduct
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This study will be carried out on 70 pregnant women referred to Rouhani hospital in Babol, Mazandaran, Iran.
The intervention group will use the syrup, in addition to the nutritional and physical activity recommendations. Three days later, if there is no defecation, 25% added to the dose.
Patients are checked in one and two weeks and the constipation checklist will be completed.
The control group also received nutrition and physical activity recommendations, and the checklists will be completed in the first and second weeks after the start.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Age 17-35 years. Gestational age 28-40 weeks. constipation was based on the criteria of the study (less than 3 times/week defecation, pain while defecation, stool stiffness).
exclusion criteria: high risk pregnancy. The history of inflammatory bowel disease,intestinal surgery,smoking,drug abuse,history of Rheumatologic diseases
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Intervention groups
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In the intervention group, cassia fistula syrup will be given to 35 women who had a diagnosis of constipation based on the criteria of the study, twice a day for 2weeks, in addition to nutritional and physical activity recommendations. In the control group, 35women who matched with the intervention group received only nutritional and physical activity recommendations
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Main outcome variables
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The frequency of defecation per week
General information
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Reason for update
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Because of our patient age ,we want to entering age between 17 to 38
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20100704004306N11
Registration date:
2020-02-13, 1398/11/24
Registration timing:
registered_while_recruiting
Last update:
2020-05-27, 1399/03/07
Update count:
1
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Registration date
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2020-02-13, 1398/11/24
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-02-09, 1398/11/20
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Expected recruitment end date
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2020-05-09, 1399/02/20
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The efficacy of cassia fistula syrup on constipation in pregnant women
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Public title
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The efficacy of cassia fistula syrup on constipation in pregnant women
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Satisfaction with entering the study
Age between 17and 38 years
Gestational age 28-40 weeks
Diagnosis of constipation based on study criteria (defecation less than 3 times a week, pain while defecating and stool stiffness)
Exclusion criteria:
High risk pregnancy (twin pregnancy, abortion, placenta previa, preterm labor, fetal anomaly)
History of inflammatory bowel disease (Crohn's disease, ulcerative colitis)
History of intestinal surgery
Smoking and drug abuse
Rheumatologic diseases
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Age
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From 17 years old to 38 years old
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Gender
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Female
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Phase
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1-2
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Groups that have been masked
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No information
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Sample size
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Target sample size:
70
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization is performed for two groups in blocks of 4. Patients will randomly divide into two groups: intervention 1 and intervention 2 (intervention 1: nutritional and physical activity recommendations and intervention 2: dietary recommendations and physical activity + cassia fistula syrup).
Random permuted blocks (blocks containing 4 of A and B) will be prepared and eligible samples will be assigned to two intervention groups.
Intervention groups 1 and 2 are each marked with one of the letters A and B, and cards with different quadruple combinations of letters A and B will be produced.
Picking up the cards randomly will determine the following 4 patients will be placed in which of the intervention groups.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-03-03, 1397/12/12
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Ethics committee reference number
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IR.MUBABOL.REC.1397.058
Health conditions studied
1
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Description of health condition studied
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Constipation in pregnant wemon
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ICD-10 code
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K59.0
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ICD-10 code description
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Constipation
Primary outcomes
1
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Description
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frequency of defecation per week
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Timepoint
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Before intervention and one and two week after intervention
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Method of measurement
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Constipation cheklist
Intervention groups
1
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Description
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The intervention group (35 pregnant women) will received nutritional and physical activity recommendations. Also, for two weeks,1 tbsp containing 10 cc of the cassia fistula syrup ("Flubel" syrup produced by Sanabel Daru Co.) twice a day will be given. If constipation does not improve, patients can increase the dose of the drug to 30 cc daily and record this amount.
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Category
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Treatment - Drugs
2
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Description
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In the control group (35 pregnant women) only nutritional and physical activity recommendations are given.These recommendations include a written text on the need for adequate fluids, fiber foods, and the need for regular daily physical activity.
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Category
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Lifestyle
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Babol University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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The result will be sharing
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When the data will become available and for how long
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The results of the study will be published at least one year after sampling and analyzing the data.
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To whom data/document is available
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Academic researchers can apply to study documents
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Under which criteria data/document could be used
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Available for systematic review studies
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From where data/document is obtainable
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Dr. Seyyed Ali Mozaffarpur is responsible for reviewing requests and information.
Call: 00989111139105 or email: seyyedali1357@gmail.com
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What processes are involved for a request to access data/document
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Dr. Seyyed Ali Mozaffarpur is responsible for reviewing requests and information.
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Comments
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